Asuncion

Researchers are evaluating the Spinal Stabilization Technologies PerQdisc Nucleus Replacement System in patients with degenerative disc disease (DDD) affecting one or more lumbar discs, specifically between L1 and S1. This prospective, open-label, multi-center study aims to collect additional safety and effectiveness data for this minimally invasive device. The PerQdisc Nucleus Replacement Device (NRD) is designed to replace a damaged nucleus pulposus surgically, with the goal of reducing chronic low back pain by preserving disc height and maintaining spinal range of motion, offering an alternative to spinal fusion surgery. Participants will undergo nucleus replacement surgery with the PerQdisc device using standard anterior, lateral, or minimally invasive posterolateral surgical approaches. The study includes 72 patients and requires approval by a Medical Advisory Board before surgery. The device replaces the damaged disc material and is intended for single-level treatment. The study does not involve a comparison group but focuses on evaluating the device's performance and safety. During the study, participants will be assessed using the Oswestry Disability Index (ODI) and Visual Analog Scale (VAS) for low back pain at 6 and 12 months post-treatment. Safety will be monitored by tracking device expulsion and failure over the same periods. Participants will also undergo various evaluations, including imaging and clinical assessments, to ensure appropriate eligibility and monitor outcomes. The total follow-up period includes assessments up to 12 months after surgery to evaluate both the device's effectiveness and safety profile.

Researchers are evaluating the safety and performance of the Neurotronic Infusion Catheter for treating adults with Type 2 Diabetes Mellitus (T2DM), hypertension, and obesity. This prospective, single-arm, multi-center trial focuses on chemical denervation of the renal and hepatic arteries to address these conditions. The study is a Phase 1 trial aiming to assess device success during the procedure and monitor serious device- and procedure-related complications within 30 days after treatment. The treatment involves ethanol ablation of the renal and common hepatic arteries using the Neurotronic Infusion Catheter. Participants receive this catheter-based chemical denervation procedure targeting arteries with specific vessel diameters and lengths. The study does not include a comparison group but follows participants closely to evaluate safety and device performance during and after the procedure. Participants undergo screening for eligibility, and during the study, researchers will assess device success during the intervention and track any serious complications for 30 days afterward. Monitoring includes evaluations of safety outcomes and procedural results. The total participation timeline involves the procedure day and a follow-up period of 30 days to capture relevant safety data and treatment effects.

Researchers are studying Latin American adults with moderate to severe obstructive sleep apnea (OSA) to better understand their upper airway characteristics and how they respond to a neuromodulation therapy. This early phase 1 study aims to compare responses with previous U.S.-based studies, focusing on airway collapse patterns and treatment effects using special scoring methods during sleep. Participants will undergo an overnight sleep study followed by a drug-induced sleep endoscopy (DISE) procedure with phrenic nerve stimulation during a 30-minute research session. This approach helps assess the airway's behavior and the potential effectiveness of this neuromodulation therapy for treating OSA. During the study, researchers will use VOTE scoring and airway measurements to evaluate upper airway collapse and response to treatment. They will monitor participants from enrollment until study exit, usually within three weeks of screening. The study also involves tracking apnea and hypopnea events and other sleep-related measures to understand treatment impact and safety.

Researchers are evaluating the safety and feasibility of the Tioga TMVR System in treating patients with symptomatic mitral regurgitation (MR) of moderate to severe grade (3+ or higher). This prospective, single-arm, multi-center study plans to enroll up to 30 patients who have heart valve disease and are not ideal candidates for surgery or other treatments. The study aims to assess both safety and performance of this new device designed to replace the diseased mitral valve. The Tioga TMVR System involves implanting a bioprosthetic mitral valve percutaneously through transfemoral-transseptal access, replacing the native valve. Participants will receive this investigational device as a single treatment. The procedure and device use are carefully monitored to evaluate its technical success and safety. Participants will be followed from the day of the procedure through at least 30 days afterward. Researchers will measure safety outcomes during this period and assess the device's performance immediately after implantation. Participants must agree to return for follow-up visits, during which they will undergo evaluations to monitor heart function and overall health. The study collects detailed data to understand the device's effects and any potential risks over time.

Researchers are evaluating the safety and effectiveness of the Lunair Alpha System, a neurostimulator device, for treating moderate to severe sleep disordered breathing, including sleep apnea. This first-in-human study focuses on patients who do not tolerate, comply with, or have access to other treatments for sleep disordered breathing. Participants will receive an implant of the neuro stimulator device designed to treat sleep disordered breathing. The study monitors patients after the device implantation to assess its safety and how it affects their condition over time. Participants will be followed from enrollment through 12 months after the device implant, during which time researchers will monitor for any procedure or device-related adverse events. Assessments will include safety evaluations and tracking any side effects or complications related to the neurostimulator device.

Researchers are evaluating the safety and technical success of the Tangent Tricuspid Annular Therapy System in patients with severe, symptomatic functional tricuspid regurgitation. This study focuses on patients who continue to have symptoms despite optimal medical treatment, aiming to assess a device designed to repair the tricuspid valve without open surgery. The study uses a transcatheter device called the Tricuspid Annular Therapy System to repair the tricuspid valve. Patients receive this device during a procedure, and the study tracks technical success at the end of the procedure and at hospital discharge. The device's safety is measured by monitoring for major adverse events related to the device or procedure through 30 days after treatment. Participants will be assessed using imaging tests like transesophageal and transthoracic echocardiograms to confirm their condition and guide the procedure. They will have follow-up visits after the procedure to monitor safety and effectiveness, including evaluations of valve function and any complications. The primary outcomes include the proportion of patients free from major adverse events within 30 days and technical success of the procedure at discharge.

Researchers are evaluating the safety and effectiveness of the Healionics STARgraft (10401) hemodialysis access graft in patients with End Stage Renal Disease (ESRD) who require hemodialysis through a prosthetic vascular graft. This single-site, prospective, single-arm study aims to compare the STARgraft's performance with prior ePTFE graft controls and published results over a 6-month period, with potential additional data collection up to 36 months after implantation. Participants will receive a 6mm diameter STARgraft (10401) implanted as an upper arm Brachial Artery to Axillary Vein shunt to provide access for hemodialysis. The study focuses on the use of this device in patients expected to need dialysis within 2 months and who meet specific anatomical and cardiac criteria. The implantation procedure and device use are closely monitored throughout the study period. During the study, participants will be followed for at least 6 months to assess the primary outcomes, including the graft's unassisted patency and safety in terms of serious device-related adverse events. Researchers will monitor patients through clinical assessments and imaging to ensure graft function and safety. The study also evaluates longer-term outcomes up to 36 months post-implantation if data are available, allowing for extended observation of device performance and patient health.